Clinical Trials FAQs

Clinical research studies are research studies in which patients help physicians and scientists find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer, and help advance the understanding of cancer and its impact.

Sylvester conducts a wide range of clinical research studies and has between 200 and 300 clinical trials available at any given time.

A clinical trial is one of the final stages of a long and careful cancer research process. Cancer researchers begin clinical trials of new drugs only after they have tested them in cancer cells grown in the laboratory and in laboratory animals. Treatments that show the most promise in these early experiments are studied using clinical trials in patients. Clinical trials for cancer patients aim to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. Participation in a clinical trial is strictly voluntary.

Involvement in a clinical trial is strictly voluntary, but people who participate can experience benefits such as:

Access to promising drugs, medical devices, or treatment approaches before these are available as standard of care options

Free or subsidized cancer treatment for the duration of the trial

A more active role in your own health care

Expert medical care at a leading cancer center

Close monitoring of your treatment and side effects

The opportunity to make a difference and improve treatments for future generations

Clinical trials have played an important role in the fight against cancer. Participating in a clinical trial contributes to medical knowledge. Many people with cancer are now living longer because treatments are more effective due to clinical trials. If you decide to participate in a clinical trial at Sylvester, you will play in important role in advancing scientific knowledge and helping future patients.

Clinical Trial Protocol Review
Clinical trials are conducted according to a protocol plan carefully designed to safeguard the health of the volunteer participants while aiming to answer specific research questions. The protocol includes the following information:

Purpose of the study

The study design

How many people will participate

Who is eligible to participate in the study and who will be excluded

Details about schedule of tests, procedures and medications and their dosages

The length of the trial

The type of information that will be collected

The end points

A clinical trial is led by a principal investigator, who is usually a physician. He or she runs the clinical trial and makes sure that the clinical and research team follows the plan. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are acceptable and are justified by any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and other members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.

Informed Consent
Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with the illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Informed consent is the process of providing potential volunteer participants with information about a clinical trial before they decide whether to participate. The process of informed consent continues providing information updates to enrolled participants during the course of the study. Translation or interpretation assistance can be provided for participants with limited English proficiency.

The research team provides an informed consent document that includes study details, such as study purpose, duration, required procedures, risks and potential benefits, alternatives to the study, and who to contact for further information. The participant then decides whether to sign the document.

Informed consent is not a contract and volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time.

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows physicians and scientists to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:

Phase I Trials: These evaluate how a new drug can be provided safely including proper dosing and potential side effects. A phase I trial usually enrolls only a small number of patients or healthy volunteers, sometimes as few as a dozen. Phase I trials are the first studies in humans, and, as a result, an important step to transition novel treatments from the laboratory to the bedside. The Phase I Clinical Trials Program at Sylvester helps doctors and scientists establish collaborative relationships that often translate into new treatment choices for patients.

Phase II Trials: These studies use the results from Phase I trials regarding maximum tolerated dosages and dose-limiting toxicities. Phase II trials continue to test the safety of the drug and begin to evaluate how well the new drug works. Usually, these studies enroll a moderate number of patients.

Phase III Trials: This type of trial may test a promising new drug, a new combination of drugs, or a new surgical procedure that may increase cure rates or decrease side effects of treatment in comparison to the current standard of care. A participant will be assigned to the standard treatment or the new treatment at random (called randomization). Phase III trials often enroll large numbers of patients and may be conducted at many cancer centers nationwide or worldwide. Phase III trials may lead to FDA (Food and Drug Administration) approval of a new drug or treatment.

Phase IV Trials: These include the continuing evaluation that takes place after FDA approval, when the drug is already on the market and available for general use (post-marketing surveillance), to find more information about long-term side effects.

The National Institutes of Health Roadmap for Medical Research calls for providing “the necessary foundation for advancing basic and clinical research” to speed promising therapies from the laboratory into the clinic for patient care. The Phase I Clinical Trials Program at Sylvester was created to fulfill this philosophy within a safe environment.

The program is comprised of a multidisciplinary team of physicians, scientists, pharmacists, laboratory technicians, nurses, statisticians, research coordinators, and data managers. This team has dedicated laboratory, pharmacy, and chemotherapy administration areas, which all work together to provide the highest standard of care to patients who participate in Phase I trials.

Phase I trials are the first studies in humans and, as a result, form an important step to transition novel treatments from the laboratory to the bedside. The Phase I Clinical Trials Program helps physicians and scientists establish collaborative relationships that often translate into more treatment choices for patients:

The Phase I Clinical Trials Program at Sylvester is South Florida’s only academic Phase I testing center dedicated to drug development for cancer patients.

Sylvester also has Alex’s place, the only Pediatric Phase I Clinical Trials Program in South Florida, with the goal of fostering more collaboration between Sylvester scientists and pediatric oncologists. More than simply a treatment site for children with cancer and blood diseases, Alex’s place is a space designed to empower our young patients and support their families. Learn more about pediatric cancer and Alex’s place.

Once a clinical trial is completed, the information collected during the study is carefully examined by the principal investigator and the research team to make decisions about the meaning of the findings and the potential need for further testing.

When a Phase I or II trial is completed, the investigators decide whether these early results justify moving on to the next study phase.

After a Phase III trial is completed, researchers scrutinize the data to decide how to interpret the results. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. Once a new approach has been proven safe and effective in a clinical trial, it may become the new standard of medical practice.